Terry White Chemists Simvastatin

TERRY WHITE CHEMISTS SIMVASTATIN Tablet

Contains the active ingredient simvastatin

Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about Terry White Chemists Simvastatin. It does
not contain all the information that is known about
Terry White Chemists Simvastatin. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is Terry White Chemists Simvastatin tablet. It contains the active ingredient simvastatin.

It is used to help lower high cholesterol and triglyceride levels (together with diet and other lifestyle changes - discuss
these with your doctor).

Simvastatin is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have
diabetes, a history of stroke, or other blood vessel disease).

Simvastatin may be used, regardless of cholesterol level, to:

help prolong life by reducing the risk of a heart attack

reduce the risk of stroke

reduce the need for surgery to increase blood flow to the heart

reduce the need for hospitalisation due to angina.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed
this medicine for another reason.

This medicine is available only with a doctor's prescription.

Cholesterol:

Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things,
including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol
can be a problem. Your body makes cholesterol, but it also comes from food.

Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol
comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and
your cholesterol levels rise.

High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.

When you have high levels of cholesterol, it may 'stick' to the inside of your blood vessels instead of being carried to the
parts of the body where it is needed. Over time this can form hard areas called plaque, on the walls of blood vessels, making
it more difficult for the blood to flow. This blocking of your blood vessels can lead to CHD (such as heart attack and angina)
and stroke.

There are different types of cholesterol, called LDL and HDL cholesterol. LDL cholesterol is the 'bad' cholesterol that can
block vessels. HDL cholesterol, on the other hand, is the 'good' cholesterol that is thought to remove the bad cholesterol
from the blood vessels.

Triglycerides:

Triglycerides are an energy source for the body. However, as with cholesterol, too much triglycerides can be a problem.

How it works

Simvastatin belongs to a group of medicines known as HMG-CoA reductase inhibitors.

In people with CHD, simvastatin may slow down the hardening of blood vessels and reduce the risk of developing new plaque.

In people with high cholesterol, it works by reducing the amount of cholesterol made by the liver. In terms of good (HDL)
and bad (LDL) cholesterol, simvastatin reduces the bad cholesterol and raises the good cholesterol.

Simvastatin does not reduce the cholesterol and triglycerides that come from fat in food. Therefore, when you are taking simvastatin,
you also need to follow a low fat diet and other measures, such as exercise and weight control.

In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides
with a simple blood test.

There is no evidence that this medicine is addictive.

Use in children

Safety and effectiveness have not been studied in boys under 10 years of age or in girls who have not yet started their periods.

Before you take this medicine

When you must not take it

Do not take this medicine if:

You are pregnant or there is a chance that you could become pregnant (e.g. not using adequate contraception).

Simvastatin may affect your developing baby if you take it during pregnancy.

You are breast-feeding.

Your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

You have liver disease or unexplained high levels of liver enzymes called serum transaminases.

You have had muscle pain, tenderness or weakness (myopathy) from other medicines used to treat high cholesterol or triglycerides.

erythromycin, clarithromycin and telithromycin, antibiotics used to treat infections

nefazodone, used to treat depression.

You are hypersensitive to, or have had an allergic reaction to, simvastatin or any of the ingredients listed at the end of
this leaflet.

Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the
face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.

If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately
or go to the Accident and Emergency department at the nearest hospital.

You are allergic or intolerant to lactose. These tablets contain lactose.

It has passed the expiry date (EXP) printed on the pack.

The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1.You have allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes.

2.You have or have had any medical conditions, especially the following:

liver disease. Your doctor will do a blood test to make sure you have no problems with your liver

kidney disease, thyroid problems or any other medical problems

unexplained muscle pain, tenderness or weakness not caused by exercise.

3.You drink alcohol regularly.

4.You are taking niacin (also known as nicotinic acid) or a niacin-containing product, particularly if you are Chinese.

5.You are currently pregnant or you plan to become pregnant.

Simvastatin must not be used during pregnancy or if there is a possibility of pregnancy.

6.You are currently breastfeeding or you plan to or breastfeed

Simvastatin must not be used or while breastfeeding.

7.You are planning to have surgery or an anaesthetic.

8.You are currently receiving or are planning to receive dental treatment.

9.You are taking or are planning to take any other medicines.

This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

erythromycin, clarithromycin and telithromycin, antibiotics used to treat infections

nefazodone, used to treat depression.

Some other medicines may also interact with simvastatin. These include:

other medicines used to lower cholesterol levels, such as other fibrates, niacin (also known as nicotinic acid)

warfarin and other medicines used to prevent blood clots

colchicine, used for gout

verapamil, diltiazem or amlodipine, used to treat high blood pressure, angina or other heart conditions

amiodarone, used to treat irregular heart beat

digoxin, used to treat heart problems

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with simvastatin.

Grapefruit juice, especially in large amounts, may also interfere with the way simvastatin works in your body. However one
glass of grapefruit juice per day is unlikely to have any effect.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this
leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your cholesterol and triglyceride
levels and other factors, such as kidney disease, and other medicines you may be taking.

For high cholesterol and triglyceride levels, the recommended starting dose is 10 mg or 20 mg per day, taken in the evening.

For CHD or risk of CHD, the usual starting dose is 40 mg per day, taken in the evening.

The maximum dose of simvastatin is 80 mg per day taken in the evening. This dose should only be used in patients at a high
risk of heart problems who have not achieved their treatment goals on lower doses.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow this medicine with a glass of water.

When to take it

Take this medicine once a day, in the evening.

The liver produces its greatest amount of cholesterol when the body is at rest and when there is no dietary intake. For most
people, this is at night when asleep. Therefore, this medicine is more effective when taken in the evening. A good time would
be after your evening meal. However, it does not matter whether you take it before or after food.

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also
help you remember when to take it.

How long to take it for

Simvastatin helps to lower your cholesterol. It does not cure your condition. Therefore, you must continue to take it as directed
by your doctor if you expect to lower your cholesterol and keep it down. You may have to take cholesterol-lowering medicine
for the rest of your life. If you stop taking simvastatin, your cholesterol levels may rise again.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take
it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons
Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your
nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

you are about to be started on any new medicine

you plan to have any vaccinations or immunisations

you become pregnant or plan to breastfeed (stop taking it and tell your doctor immediately)

you are about to have any blood tests

you are going to have surgery.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor
regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

give this medicine to anyone else, even if their symptoms seem similar to yours

take your medicine to treat any other condition unless your doctor tells you to

stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Avoid drinking large quantities of alcohol. Drinking large amounts of alcohol may increase the chance of this medicine causing
liver problems.

Avoid drinking large quantities of grapefruit juice.

Grapefruit juice contains one or more components that alter the metabolism of some medicines, including simvastatin.

Be careful driving or operating machinery until you know how this medicine affects you.

Simvastatin generally does not cause any problems with your ability to drive a car or operate machinery. However, as with
many other medicines, this medicine may cause dizziness in some people. Make sure you know how you react to this medicine
before you drive a car or operate machinery.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking simvastatin or if you have any questions
or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side
effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

constipation, diarrhoea, flatulence (wind)

stomach upset or pain, feeling or being sick (nausea or vomiting), acid regurgitation,

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